An observational study in Venous Thrombosis Deep (Limbs) and Venous Thrombosis, sponsored by FlowPhysix, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by FlowPhysix, Inc. · Observational
The objective of this study is to evaluate how well and how safe the FLOWRUNNER Aspiration System works for treating blood clots in the arms or legs in real-life medical settings.
The study is a registry to collect data from standard of care mechanical thrombectomy procedure using FLOWRUNNER Aspiration System. The FLOWRUNNER Aspiration System is a single use catheter based system indicated for the removal of fresh, soft emboli (a soft clot) and thrombi (a stationary clot) from vessels of the peripheral (in the arms and legs) and venous (blood vessels responsible for carrying deoxygenated blood back to your heart and lungs) system.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 218 is below the median of 301 across 274 observational studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →This is the only study on the registry with FlowPhysix, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
Eligibility Criteria:
Exclusion Criteria:
High-risk for pulmonary embolism (PE), defined as those presenting with:
Any prior or current cancer diagnosis that, in the investigator's judgment, would pose an unacceptable risk or confound study outcomes including but not limited to:
Known antiphospholipid syndrome or other high-risk coagulation disorders, including:
Chronic non-ambulatory status, defined as:
for intravascular therapy including:
Any condition that, in the investigator's judgment, would pose unacceptable risk or interfere with study participation, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study is an observational registry to collect data on the standard of care treatment of venous thrombosis. There is no investigational intervention. All participants will receive mechanical thrombectomy as standard of care.
Other: Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
Participant will receive mechanical thrombectomy for venous thrombosis as standard of care. This study is an observational registry to collect data on the standard of care non investigational intervention.
Procedure Success
The number of patients that had a response to treatment after the standard of care mechanical thrombectomy procedure with the study device, defined as removal of thrombus (a large amount of the blood clot from the vein or artery) during the study procedure.
Time frame: Immediately Post Procedure
Safety Events will measure any risks that may occur during or after the study procedure
The number of patients that have serious problems after the standard of care mechanical thrombectomy procedure that could be life threatening or cause major harm.
Time frame: Within 30 days of the study procedure
Procedure Results
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
Time frame: Immediately after the study procedure
Vein Patency
The number of patients that have vein patency as measured by duplex ultrasound or other imaging.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Vein Disability Score
The number of patients that have improvement in Vein Disability Score which is a clinical assessment by the physician to score how chronic venous disease affects a patient's mobility and daily functionality. A score of 0 means no symptoms and a score of 3 means severe disability. The total score per follow up visit will be compared to baseline.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Villalta Score
The number of patients that have improvement in Villalta Score which is a clinical assessment by the physician to score patient reported symptoms from a score of 0 to 3 based on severity. A score of 0 indicates absence of symptoms and a score of 3 indicates severe symptoms. The total score is the sum of all individual scores. 0-4 is no symptoms to \>15 is severe symptoms. Clinical signs will be scored by the physician or nurse after physical examination of the affected arm/leg.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Quality of Life
The number of patients that have an improvement of Quality of Life as measured by the EuroQol Questionnaire. It evaluates 5 dimensions of health, with 5 levels of severity for each. A score of 1 for each question is good health, a score of 5 for each question is poor health.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Additional Safety Events
The number of patients that have serious adverse events (SAEs) will be evaluated.
Time frame: Up to 24 months after the study procedure
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2026; primary completion for Sep 2028, 24 months later.
Of 127 observational studies under Venous Thrombosis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 82. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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